BEUDAMED
    FDA Adverse Event Death Summary report: N

    REMSTAR AUTO A-FLEX SYSTEM ONE

    MDR report key: 12975656 · Received December 9, 2021

    Report

    Report Number
    MW5105943
    Event Type
    Death
    Date Received
    December 9, 2021
    Report Date
    December 7, 2021
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005907
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY HUSBAND HEALTH HISTORY WAS CERVICAL SPONDYLOSIS/OSTEOPHYTOSIS. HE WAS PREVIOUSLY HEALTHY AND STRONG. HE WAS PRESCRIBED CPAP IN 2009 FOR OSA. HE HAD PNEUMONIA IN 2013 WITH HEMOPTYSIS AND WAS FOUND TO HAVE ATRIAL FIBRILLATION AT THAT TIME. THE NEXT YEAR HE WAS DIAGNOSED WITH COPD. IN 2018 HE WAS DX WITH ILD. HE CONTINUOUSLY GOT WORSE WITH MULTIPLE HOSPITALIZATIONS. HE WAS TOLD TO STOP USING HIS CPAP FEBRUARY THIS YEAR. HE WAS THEN TO HAVE A LUNG TRANSPLANT BUT DIED BEFOREHAND. I HAVE YEARS OF DOCUMENTATION. FDA SAFETY REPORT ID# (B)(4).

    Description of Event or Problem · 0

    HOLD FOR SH 12.13MY HUSBAND HEALTH HISTORY WAS CERVICAL SPONDYLOSIS/OSTEOPHYTOSIS. HE WAS PREVIOUSLY HEALTHY AND STRONG. HE WAS PRESCRIBED CPAP IN 2009 FOR OSA. HE HAD PNEUMONIA IN 2013 WITH HEMOPTYSIS AND WAS FOUND TO HAVE ATRIAL FIBRILLATION AT THAT TIME. THE NEXT YEAR HE WAS DIAGNOSED WITH COPD. IN 2018 HE WAS DX WITH ILD. HE CONTINUOUSLY GOT WORSE WITH MULTIPLE HOSPITALIZATIONS. HE WAS TOLD TO STOP USING HIS CPAP FEBRUARY THIS YEAR. HE WAS THEN TO HAVE A LUNG TRANSPLANT BUT DIED BEFOREHAND. I HAVE YEARS OF DOCUMENTATION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863934 REMSTAR AUTO A-FLEX SYSTEM ONE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC. REMSTAR AUTO A-FLEX W/HT HUM,SYS 00606959005907

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death ANORO ELLIPTA| CALCIUM/VITAMIN D| ELIQUIS| SALBUTAMOL PRN| SYNTHROID| ZOPLICONE PRN